2. CONTENTS
INTRODUCTION
NEED FOR HARMONISE
ORIGIN OF ICH
EVOLUTION OF ICH
OBJECTIVES OF ICH
PROCESS OF ICH
ICH GUIDELINES
3. INTRODUCTION
ICH stands for "International Conference on Harmonization of
Technical Requirements for Registration of Pharmaceuticals for
Human Use".
Which is international non-profit Association ,which is unique in
bringing together the regulatory authorities and pharmaceutical
industries.
Where Europeions of the Union, Japan and the USA involve in
scientific and technical d testing procedures required to assess and
ensure the safety, quality and efficacy of medicines
These are the three pillars on which the health of the patients
depend.
4. ICH Guidelines accepted as law in several Countries to ensure and
access the Q,S,E of medicines but are only used as guidance for the
U.S Food and Drug Administration.
Each regulatory co-sponsor implements the guidelines according to
its National or Regional requirements.
They are intended to be used in combination with any regional
requirements.
5. Need to HarmoniZe
Many time-consuming and expensive test procedures, in order to
market new products, internationally.
Over rising costs of health care making safe and efficacious new
treatments available to patients in need.
Divergence in technical requirements from country to country.
6. ORIGIN OF ICH
Harmonization of regulatory requirements was pioneered by the EU,
Europe, in the 1980s as the europe move towards the development
of single market.
The success achieved in europe demonstrated that harmonization
was feasible.
At the same time there were discussions between Europe, Japan
and the US on possibilities for harmonization.
The birth of ICH took place at a meeting in April 1990.
Topics selected for harmonization would be divided into safety
quality and efficacy to reflect the three criteria which are the basis
for approving and authorizing new medicinal products.
7. EVOLUTION OF ICH
First decade:
significant progress in the development of ICH Guidelines on Safety
Quality and Efficacy topics and also work on a number of important
multidisciplinary topics.
Second decade:
Implementation of 1CH Guidelines in the ICH regions. Expand
communication and information on ICH Guidelines with other regions.
Third decade:
Extending the benefits of harmonization beyond the ICH regions.
Training as well as active participation of other regions in Guideline
development is seen as key in this effort.
8. OBJECTIVES OF ICH
Promote public health by early availability of drug in the market.
Maintaining safeguards on quality, safety and efficacy.
Improve efficiency of new drug development ,Reduce registration
cost.
Less expensive drugs for patients.
Prevent the duplication of clinical trails in humans.
Minimize the animal use with out compromising in safety ,efficacy of
the product.
Mutual acceptance of clinical data by regulatory authority.
Reducing testing duplication.
9. ICH MEMBERS
EU
EFPIA (European federation of pharmaceutical industries'
associations).
MHLW (Ministry of health, Labor and welfare, Japan).
JPMA (Japan Pharmaceuticals manufacturers Association).
US FDA.
PhRMA(pharmaceutical research and manufacturers association).
Observers : WHO, TPP(canada).
International federation of Pharmaceutical manufacturer's
association.
10. ICH GUIDELINES
The guidelines of ICH are broadly categorized into four types.
1) Quality guidelines.
2) Safety guidelines.
3) Efficacy guidelines.
4) Multidisciplinary guidelines.
11. QUALITY:
Harmonization achievements in the Quality area include such as the
conduct of stability studies, defining relevant thresholds for impurities testing
and a more flexible approach to pharmaceutical quality based on Good
Manufacturing Practice (GMP) risk management.
SAFETY:
ICH has produced a comprehensive set of safety Guidelines to potential
risks like carcinogenicity. genotoxicity and reprotoxicity etc.,
EFFICACY:
The work carried out by ICH under the Efficacy heading is concerned with
the design, conduct, safety and reporting of clinical trials. It also covers
novel types of medicines derived from biotechnological processes and the
use of pharmacogenetics / genomics techniques to produce better
targeted medicines.
MULTIDISCPLINARY:
These are the cross-cutting topics which do not fit uniquely into one of the
Quality, Safety and Efficacy categories. It includes the ICH medical
terminology (MedDRA), the Common Technical Document (CTD) and the
development of Electronic Standards for the Transfer of Regulatory
Information (ESTRI).
12. QUALITY GUIDELINES
Q1A –QIF : Stability
Q2 : Analytical Validation
Q3A - Q3D : Impurities
Q4-Q4B : Pharmacopoeias
Q5A- QSE : Quality of Biotechnological Products
Q6A- Q6B : Specifications
Q7 : Good Manufacturing Practice
Q8 : Pharmaceutical Development
Q9 : Quality Risk Management
Q10 : Pharmaceutical Quality System
Q11 : Development and Manufacture of Drug Substances
Q12 : Lifecycle Management
Q13 : Continuous Manufacturing of Drug Substances and Drug Products
Q14 : Analytical Procedure Development
